Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT00473668
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Administration of one dose of hepatitis B vaccine at birth
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Hepatitis B vaccine received after the first week of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
* History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
8 Weeks
Study:
NCT00473668
Study Brief:
Protocol Section:
NCT00473668